EUCTR2019-003334-16-LV进行中（未招募）1 期
Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Signed informed consent,
- •Man or woman between 18 and 75 years of age,
- •Acute ulcerative colitis,
- •New diagnosis or established disease,
- •diagnosis confirmed by total colonoscopy and biopsy
- •Mildly to moderately active ulcerative colitis (3 < modified UC-DAI < 11), with rectal bleeding subscore of = 1, and endoscopic subscore of = 2 at the most active site in the segment of the rectum
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 282
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 78
排除标准
- •Crohn’s disease, indeterminate colitis, ischemic colitis, diverticular disease-associated colitis, microscopic colitis
- •Presence of colitis of a different origin (e.g. infectious or parasitic, drug-induced),
- •Previous colonic surgery (except appendectomy, haemorrhoidectomy, and endoscopic removal of polyps),
- •Abnormal laboratory values, presence of or suspected concomitant disease(s) that could affect study-specific assessments and/or their evaluation, or might compromise patients' safety and/or compliance (e.g. organic diseases or infections of the gastrointestinal tract (with exceptions), certain malignancies or cancers, certain metabolic disorders)
- •Regular oral treatment with more than 2.4 g/d mesalazine (or therapeutic equivalent, i.e., either > 2.4 g/d olsalazine, > 5.6 g/d balsalazide, or > 6.2 g/d sulfasalazine) within the last 4 weeks prior to baseline,
- •Regular rectal treatment with more than 0.5 g/d mesalazine, olsalazine or more than 1 g/d sulfasalazine within the last 4 weeks prior to baseline,
- •Oral/rectal/intravenous corticosteroids therapy within the last 4 weeks priorto screening endoscopy,
研究者
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